Docetaxel in Treating Patients With Advanced Cancer of the Cervix
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ClinicalTrials.gov Identifier: NCT00003445 |
Recruitment Status
:
Completed
First Posted
: April 23, 2004
Last Update Posted
: June 26, 2013
|
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RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of docetaxel in treating patients with advanced cancer of the cervix.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Cervical Cancer | Drug: docetaxel | Phase 2 |
OBJECTIVES: I. Assess the antitumor activity of docetaxel as neoadjuvant chemotherapy in patients with locally advanced squamous cell carcinoma of the cervix. II. Assess the tumor response, toxic effect, and survival rate of this regimen in these patients.
OUTLINE: Patients receive docetaxel IV over 1 hour on day 1. Treatment is repeated every 3 weeks for 3 courses. Patients are followed every 3 months posttreatment.
PROJECTED ACCRUAL: A total of 16-35 patients will be accrued for this study.
Study Type : | Interventional (Clinical Trial) |
Primary Purpose: | Treatment |
Official Title: | Neoadjuvant Chemotherapy With Docetaxel in Advanced Cervical Carcinoma |
Study Start Date : | December 1997 |
Actual Study Completion Date : | April 2004 |


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Ages Eligible for Study: | Child, Adult, Senior |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Histologically proven stage IIB, IIIA, IIIB, and IVA squamous cell carcinoma of the cervix Bidimensionally measurable disease No bilateral hydronefrosis
PATIENT CHARACTERISTICS: Age: Any age Performance status: WHO 0-2 Life expectancy: At least 12 weeks Hematopoietic: Hemoglobin at least 10 g/dL Leukocytes at least 4,000/mm3 Platelet count at least 75,000/mm3 Hepatic: Bilirubin less than 1.25 times upper limit of normal (ULN) AST less than 1.25 times ULN Renal: BUN less than 30 mg/dL AND Creatinine less than 1.5 mg/dL OR Creatinine clearance at least 60 mL/min Other: No prior or other concurrent malignancies, other than properly treated basal cell skin cancer
PRIOR CONCURRENT THERAPY: Not specified

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003445
Argentina | |
Unidad Oncologica Del Comahue | |
Neuquen, Argentina, 8300 |
Study Chair: | Carlos Teodoro Vallejo, MD | Grupo Oncologico Cooperativo del Sur |
ClinicalTrials.gov Identifier: | NCT00003445 History of Changes |
Other Study ID Numbers: |
GOCS-04-CC-97 CDR0000066473 ( Registry Identifier: PDQ (Physician Data Query) ) NCI-V98-1456 |
First Posted: | April 23, 2004 Key Record Dates |
Last Update Posted: | June 26, 2013 |
Last Verified: | September 2001 |
Keywords provided by National Cancer Institute (NCI):
stage III cervical cancer stage IIB cervical cancer stage IVA cervical cancer cervical squamous cell carcinoma |
Additional relevant MeSH terms:
Uterine Cervical Neoplasms Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site Neoplasms Uterine Cervical Diseases Uterine Diseases |
Genital Diseases, Female Docetaxel Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action |